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LINEZOLID TABLETS

2016-05-03 13:27:04 来源: 作者: 【大中小】浏览:346次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use linezolid safely and effectively. See full prescribing information for linezolid.
LINEZOLID TABLETS
Initial U.S. Approval: 2000

INDICATIONS AND USAGE
Linezolid is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.1); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.2); Uncomplicated skin and skin structure infections (1.2); Vancomycin-resistant Enterococcus faecium infections. (1.3)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.4)

DOSAGE AND ADMINISTRATION

	Dosage, Route, and Frequency of Administration
Infection	Pediatric Patients	Adults and Adolescents	Duration (days)
Nosocomial pneumonia	10 mg/kg intravenous or oral every 8 hours	600 mg intravenous or oral every 12 hours	10 to 14
Community-acquired pneumonia, including concurrent bacteremia
Complicated skin and skin structure infections
Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia	10 mg/kg intravenous or oral every 8 hours	600 mg intravenous or oral every 12 hours	14 to 28
Uncomplicated skin and skin structure infections	less than 5 yrs: 10 mg/kg oral every 8 hours 5–11 yrs: 10 mg/kg oral every 12 hours	Adults: 400 mg oral every 12 hours Adolescents: 600 mg oral every 12 hours	10 to 14

DOSAGE FORMS AND STRENGTHS

Tablet: 600 mg linezolid. (3)

CONTRAINDICATIONS

Known hypersensitivity to linezolid or any of the other product components. (4.1); Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. (4.2)

WARNINGS AND PRECAUTIONS

Myelosuppression: Monitor complete blood counts weekly. Consider discontinuation in patients who develop or have worsening myelosuppression. (5.1)
Peripheral and optic neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic eva luation is recommended. (5.2)
Serotonin syndrome: Patients taking serotonergic antidepressants should receive linezolid only if no other therapies are available. Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. (5.3)
A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections. (5.4)
Clostridium difficile associated diarrhea: eva luate if diarrhea occurs. (5.5)
Potential interactions producing elevation of blood pressure: monitor blood pressure. (5.6)
Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents. (5.9)

ADVERSE REACTIONS

Most common adverse reactions (>5% of adult and/or pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. (4.2, 5.3, 5.6, 7, 12.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2015

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Pneumonia

1.2 Skin and Skin Structure Infections

1.3 Vancomycin-resistant Enterococcus faecium Infections

1.4 Usage

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Hypersensitivity

4.2 Monoamine Oxidase Inhibitors

5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

5.2 Peripheral and Optic Neuropathy

5.3 Serotonin Syndrome

5.4 Mortality Imbalance in an Investigational Study in Patients with Catheter-Related Bloodstream Infections, including those with catheter-site infections

5.5 Clostridium difficile Associated Diarrhea

5.6 Potential Interactions Producing Elevation of Blood Pressure

5.7 Lactic Acidosis

5.8 Convulsions

5.9 Hypoglycemia

5.10 Development of Drug-Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Monoamine Oxidase Inhibitors

7.2 Adrenergic and Serotonergic Agents

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Adults

14.2 Pediatric Patients

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*: Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

Linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Warnings and Precautions (5.4)].

1.1 Pneumonia

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14)].

Community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14)].

1.2 Skin and Skin Structure Infections

Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae. Linezolid has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14)].

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14)].

1.3 Vancomycin-resistant Enterococcus faecium Infections

Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14)].

1.4 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid and other antibacterial drugs, linezolid should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

The safety and efficacy of linezolid formulations given for longer than 28 days have not been eva luated in controlled clinical trials.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

The recommended dosage for linezolid formulations for the treatment of infections is described in Table 1.

Table 1. Dosage Guidelines for Linezolid
	Dosage and Route of Administration		Recommended Duration of Treatment (consecutive days)
Infection*	Pediatric Patients† (Birth through 11 Years of Age)	Adults and Adolescents (12 Years and Older)	Recommended Duration of Treatment (consecutive days)
* Due to the designated pathogens [ see
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